BEDFORD, Mass. (January 6, 2009) / b3c newswire / - Hologic, Inc. (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that it has received CE marking approval for its Adiana® permanent contraception system. The Adiana system is designed to provide a minimally-invasive, non-incisional alternative to traditional, surgical means of female sterilization.

The Adiana procedure utilizes hysteroscopy, generally requires only local anesthesia, and can be performed in a physician’s office. Patients are normally able to return to work or resume their everyday activities within a day. In contrast, bilateral tubal ligation — commonly referred to as “getting your tubes tied” — is typically performed in a hospital operating room under general anesthesia and requires the physician to make one or two incisions in the abdomen. This usually requires approximately four to five days of recuperation.

CE marking approval allows Hologic to market the Adiana system in the 27 countries of the European Union (EU) and three of the four member states of the European Free Trade Association (EFTA). CE marking is recognized in many countries outside the European Economic Area giving Hologic the ability to supply systems to a number of markets internationally. In the United States, the pre-market approval (PMA) application for the Adiana permanent contraception system is currently under Food and Drug Administration (FDA) review. Hologic is also in the process of registering the Adiana system in Canada and Australia.

“This is another significant milestone for Hologic and our GYN surgical products business,” said Tony Kingsley, senior vice president and general manager, Hologic GYN surgical products. “Europe is a key area of growth for us and where we have a formidable sales and marketing infrastructure in place and solid support from key opinion leaders. The Adiana permanent contraception system offers a novel approach to permanent contraception and is designed to provide several advantages over existing non-incisional methods, including ease of use for the physician, which can result in more safe and successful procedures for the patient.”

“Hysteroscopic sterilization gives women another choice in permanent sterilization,” adds Andrew Baxter, MRCOG, consultant, honorary senior lecturer, Department of Obstetrics andGynecology, The Royal Hallamshire Hospital, Sheffield, UK. Mr. Baxter has been performing hysteroscopic sterilizations for the last six years. “It also allows them to avoid hospital admission, anaesthetic and the discomfort and risks attached to laparoscopy (a keyhole examination of the abdomen). We find that our patients can go home after half an hour and are back to normal within a couple of days. Patient satisfaction levels are very high. The Adiana system is a new technique to the UK which we hope will allow more women to have access to this exciting procedure.”

Forward Looking Statement DisclaimerThis News Release may contain forward-looking information that involves risks and uncertainties, including statements about the effect and adoption of the use of the Adiana system. There can be no assurance that the system will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the Adiana system can only be determined on a case-by-case basis depending on the particular circumstances of the procedure and patient in question. Thus there can be no assurance of general adoption of this technology by the medical community. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in Hologic’s expectations or any change in events, conditions or circumstances on which any such data or statements are based. Certain factors that could adversely affect Hologic’s business and prospects are described in Hologic’s filings with the Securities and Exchange Commission.

Contact

Jim Culley, Ph.D.Director of MarketingHologic, Inc781-999-7583
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Jeff KeeneDirector of Global CommunicationsHologic, Inc.Hologic, Inc.508-263-8957
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Frequently Asked Questions

What are the major advantages of the Hologic Adiana® permanent contraception system versus traditional surgical means of female sterilization?The Adiana system is designed to provide a minimally-invasive, non-incisional alternative to traditional, surgical means of female sterilization. The Adiana procedure utilizes hysteroscopy, generally requires only local anesthesia, and can be performed in a physician’s office. Patients are typically able to return to work or resume their everyday activities within a day. In contrast, bilateral tubal ligation — commonly referred to as “getting your tubes tied” — is typically performed in a hospital operating room under general anesthesia and requires the physician to make one or two incisions in the abdomen. This usually requires approximately four to five days of recuperation

How does the Adiana system work?The system enables a novel, two-step approach to permanent contraception. First, a catheter is positioned immediately inside the opening of the patient’s fallopian tube using a hysteroscope, eliminating the need for any incisions. The catheter applies a very low-level of bi-polar radiofrequency (RF) energy to remove just a thin layer of cells that line a 1cm section of the inside of the fallopian tube. The catheter then delivers a soft polymer implant, called a “matrix,” which remains within the prepared section of the tube. The matrix is smaller than a grain of rice. The procedure is then repeated on the other fallopian tube. The procedure is designed such that healthy tissue will grow into the matrix to create a complete blockage of each tube. A confirmatory dye test called a hysterosalpingogram (HSG) is conducted at three months post-procedure to ensure the fallopian tubes are completely blocked and that the woman can begin relying on Adiana for permanent contraception.

With CE marking approval, where can the Adiana system be sold?CE marking approval allows Hologic to market the Adiana system in the European Economic Area which includes the 27 countries of the European Union (EU) and three of the four member states of the European Free Trade Association (EFTA). In addition, CE marking is recognized in many countries outside the European Economic Area giving Hologic the ability to supply systems to a number of international markets with little or no additional local authorization.

Where else is Hologic planning to market the Adiana system? In the United States, the pre-market approval (PMA) application for the Adiana permanent contraception system is currently under Food and Drug Administration (FDA) review. Hologic is also in the process of registering the Adiana system in Canada and Australia.

Where were the safety and effectiveness studies for the Adiana system performed?The pivotal clinical trial to demonstrate the safety and effectiveness of the Adiana system in providing permanent contraception was conducted in the United States, Australia, and Mexico. As part of the clinical trial, 645 women between the ages of 21 and 45 had treatment attempted with the Adiana system. The procedure showed a strong safety profile, with very high device placement success, patient tolerance, comfort, and satisfaction. A pregnancy prevention efficacy rate of 98.9 percent after 12 months of reliance on the Adiana device was demonstrated, successfully meeting the trial’s primary endpoint.

What are the synergies between the Hologic NovaSure® system for excessive menstrual bleeding and the Adiana system for permanent contraception?With the market approval of the Adiana system, Hologic is in the unique position of being able to provide European physicians with non-hormone, minimally-invasive therapies that address two significant issues for women in their post-childbearing years: contraception and heavy uterine bleeding. Both products will be sold using the same sales force and marketed through the same distribution channels.

What is hysteroscopy? What is laparoscopy?Hysteroscopy is a procedure that allows a gynecologist to look inside a woman’s uterus.Laparoscopy is a surgical procedure that uses a thin, lighted tube called a laparoscope inserted through an incision in the abdominal wall.